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510(k) Data Aggregation
(88 days)
The Advantage Multiple Drugs of Abuse Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of one to five of the following Drugs of Abuse at the indicated cut off: THC 50ng/mL, Phencyclidine (PCP) 25ng/mL, Opiates 2000 ng/mL, Cocaine 300ng/mL, Amphetamine 1,000ng/mL and Methamphetamine 1,000ng/mL. The tests are formatted in multiple plastic test cards, which hold up to 5 drug test strips, and single plastic test cards which hold one drug test strip. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS. The test is for professional use.
The Advantage Multiple Drugs of Abuse Test is an immunochromatographic based one step in vitro test. The tests are formatted in a multiple plastic card, which holds up to 5 drug test strips, and a single plastic test card, which holds a single drug test strip.
Here's a breakdown of the acceptance criteria and study information for the Advantage Multiple Drugs of Abuse Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Drug Tested | Cut-off Concentration (ng/mL) | Acceptance Criteria (Correlation) | Reported Device Performance (Correlation) |
|---|---|---|---|
| THC | 50 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Benzoylecgonine/Cocaine | 300 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Opiates | 2,000 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Methamphetamine | 1,000 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| Amphetamine | 1,000 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
| PCP | 25 | Not explicitly stated as a number, but implied by "substantially equivalent" | 90-96% (vs. GC/MS), >99% (vs. EMIT in drug-free urine) |
Note: The acceptance criteria are not explicitly numerical targets in the summary but are represented by the claim of "substantial equivalence" to GC/MS and EMIT testing, with the provided correlation percentages demonstrating this equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided document. The summary only mentions "individual Advantage drug tests" were evaluated.
- Data Provenance: Not specified. It's likely the testing was conducted in a laboratory setting, but the country of origin or whether the samples were retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable and not provided. The ground truth was established by laboratory reference methods (GC/MS and EMIT), not by human expert opinion.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods are typically used when subjective human interpretation is involved. For a diagnostic test compared to objective lab measurements like GC/MS and EMIT, adjudication is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in-vitro diagnostic test for drugs of abuse; it is not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data (correlations) are for the device itself as a standalone diagnostic tool, comparing its results directly against reference methods (GC/MS and EMIT). There is no "human-in-the-loop" component described for interpreting the primary device result. Although a human reads the test result, the performance metrics are for the device's accuracy in producing that result.
7. The type of ground truth used:
- Laboratory Reference Standards:
- GC/MS (Gas Chromatography/Mass Spectrometry): Considered a "gold standard" for drug testing, providing definitive identification and quantification of substances.
- EMIT (Enzyme Multiplied Immunoassay Technique): Another immunoassay method for screening drugs, specifically used for comparison in "drug-free urine."
8. The sample size for the training set:
- Not applicable and not provided. This device is an immunochromatographic test, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The test's design is based on chemical and biological principles rather than data-driven learning.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, there is no "training set" for this type of device. The accuracy of the device is assessed against established laboratory reference methods using test samples.
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(86 days)
The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:
| THC | 50ng/mL |
|---|---|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.
The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
The provided text does not contain detailed information about a study proving the device meets acceptance criteria. It primarily focuses on the regulatory submission, device description, intended use, and substantial equivalence to other devices.
However, based on the context of a drug test, we can infer some general acceptance criteria and what a typical study for such a device would entail. I will use the available information to construct the response, and clearly indicate where assumptions or general knowledge about drug testing device studies are used.
Acceptance Criteria and Device Performance (Inferred/General)
Since this is an immunoassay for drug detection, key performance metrics usually involve sensitivity, specificity, and accuracy against a gold standard method. The document specifies "cut-off concentrations," which are crucial for defining performance.
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/General expectation for this type of device) |
|---|---|
| Sensitivity (Ability to correctly identify positive samples at or above cut-off) | High (e.g., >95% for each drug) |
| Specificity (Ability to correctly identify negative samples below cut-off) | High (e.g., >95% for each drug) |
| Accuracy (Overall agreement with the gold standard) | High (e.g., >95% for each drug) |
| Precision/Reproducibility (Consistency of results) | Consistent results across replicates and different operators. |
| Interference (Lack of interference from common substances) | Minimal interference from common medications or urine adulterants. |
| Cut-off Concentration Performance (Correct detection at specified cut-offs) | Accurate detection at THC: 50ng/mL, PCP: 25ng/mL, Opiates: 2000ng/mL, Cocaine: 300ng/mL, Methamphetamine: 1000ng/mL. |
Study Details (Largely Inferred based on typical drug test validation studies, as specific study details are not provided in the input)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. For a multi-analyte home drug test, test sets typically involve hundreds to thousands of urine samples, covering a range of concentrations around the cut-off (negative, near cut-off, positive). This would include samples spiked with known drug concentrations and potentially clinical samples.
- Data Provenance: Not specified. Typically, studies for such devices involve a mix of spiked samples (known concentrations prepared in a lab) and clinical urine samples collected retrospectively or prospectively from individuals who may or may not have used the drugs. The country of origin for the data is not mentioned but would likely be the USA if the submission is for FDA approval.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the traditional sense for drug tests. The "ground truth" is established by a highly sensitive and specific analytical method, not by expert consensus for interpretation of results.
- Qualifications of Experts: Not applicable. The "experts" would be laboratory technicians or chemists operating the confirmatory method (GC/MS).
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Adjudication method for the test set:
- Method: Not applicable. The "ground truth" for drug presence and concentration in urine is determined by a definitive analytical method, most commonly Gas Chromatography/Mass Spectrometry (GC/MS), as explicitly mentioned in the document ("Confirmation, using GC/MS, of any possible drug result is recommended as the second step"). There is no subjective interpretation requiring adjudication of results from the reference method.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
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MRMC Study: Not mentioned and highly unlikely for this type of device. MRMC studies are typically for image-based diagnostics where human interpretation is a primary variable. For a qualitative, visually read immunoassay, the "reader" is usually the end-user (a layperson for a home test) following instructions. The performance is assessed on how accurately the device itself reflects the presence of the drug, not on improved human reading with AI assistance.
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Effect Size of AI vs. without AI assistance: Not applicable, as AI assistance is not described or implied for this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the core "performance" of the Peace of Mind Home Drug Test itself is a standalone assessment. The device is a qualitative immunoassay. The study would assess how well the device, when read according to its instructions (presumably by a human), matches the GC/MS results. While a human reads the test, the performance is inherently of the device's chemical reaction and visual output. The device itself produces the "result" (line or no line), and the human merely observes it.
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The type of ground truth used:
- Type: Analytical Gold Standard (GC/MS - Gas Chromatography/Mass Spectrometry). The document explicitly states: "Confirmation, using GC/MS, of any possible drug result is recommended as the second step." This indicates that GC/MS is the definitive method for validating the presence and concentration of drugs.
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The sample size for the training set:
- Sample Size: Not applicable. Immunoassays are not "trained" in the same way machine learning algorithms are. Their performance is inherent to their chemical design. While development and optimization use various samples, there isn't a "training set" in the sense of AI or statistical modeling.
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How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable for a training set, as there isn't one in the AI sense. During the development and validation phase, ground truth for sample characterization (e.g., preparation of spiked samples to known concentrations, or confirmation of clinical samples) would be established using GC/MS.
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(48 days)
The Advantage Marijuana (THC) and Cocaine Home Drug Test is designed for the qualitative determination of THC (cannabinoids) in human urine at a cut off level of 50ng/mL and Cocaine metabolites at a cut off of 300ng/mL.
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of THC and /or Cocaine in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
The Advantage Marijuana (THC) and Cocaine Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
This 510(k) submission (K011962) describes the "Advantage Marijuana (THC) and Cocaine Home Drug Test." The information provided mainly focuses on the regulatory aspects and intended use of the device. Consequently, detailed clinical study data, including specific acceptance criteria and study design elements, are not fully elaborated in the provided text.
Based on the available information, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states the intended cut-off levels for both substances, which act as the functional acceptance criteria for the qualitative detection. However, it does not present a table of acceptance criteria or explicitly report device performance metrics like sensitivity, specificity, or accuracy against these criteria.
| Acceptance Criteria (Cut-off Level) | Reported Device Performance |
|---|---|
| Marijuana (THC): 50 ng/mL | Not explicitly reported in terms of standard performance metrics (e.g., sensitivity, specificity, accuracy) within the provided text. The device is "designed for the qualitative determination of THC (cannabinoids) in human urine at a cut off level of 50ng/mL." |
| Cocaine metabolites: 300 ng/mL | Not explicitly reported in terms of standard performance metrics (e.g., sensitivity, specificity, accuracy) within the provided text. The device is "designed for the qualitative determination of Cocaine metabolites at a cut off of 300ng/mL." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include any information about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not include any information about the number of experts used to establish ground truth or their qualifications. Given that this is an in-vitro diagnostic device for home use, it's possible that the "ground truth" establishment might not involve "experts" in the clinical imaging sense, but rather laboratory analysis.
4. Adjudication Method for the Test Set
The provided text does not include any information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically performed for imaging or interpretation-based diagnostic devices where human readers are involved. This device is an immunochromatographic home drug test. Therefore, it is highly unlikely and not applicable for this type of device. The text does not mention any such study.
6. Standalone (Algorithm Only) Performance
This device is an immunochromatographic test, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The device itself performs the detection.
7. Type of Ground Truth Used
The "ground truth" for this type of immunoassay is established by confirmatory laboratory testing, specifically GC/MS (Gas Chromatography/Mass Spectrometry). The 510(k) clearly states: "Confirmation, using GC/MS, of any possible drug result is recommended as the second step." This indicates that GC/MS would be the reference method for establishing the true presence or absence of the drugs and their metabolites at the specified cut-off levels.
8. Sample Size for the Training Set
The provided text does not include any information about the sample size for the training set. For an immunoassay, "training set" might refer to the samples used during assay development and optimization, rather than a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not explicitly state how the ground truth for any "training set" was established, but it is highly probable that it would also be through GC/MS (Gas Chromatography/Mass Spectrometry), similar to the confirmation method mentioned for user results. This is the gold standard for drug quantification in urine.
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(90 days)
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(52 days)
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(31 days)
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(50 days)
The Advantage hCG Test (Urine/Serum) is a qualitative, rapid immunochromatographic assay used to detect the presence of hCG in human urine and serum for the early detection of pregnancy. The test is intended for use in clinical laboratories by health care professionals.
The Advantage hCG Test (Urine/Serum) is an immunochromatographic based one step in vitro test.
The Advantage Diagnostics Corporation Advantage hCG Test (Urine/Serum) is an immunochromatographic assay designed for the qualitative detection of hCG in human urine and serum as an early indication of pregnancy.
Here's an analysis of its acceptance criteria and the study proving its performance:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrate substantial equivalence in performance characteristics to a legally marketed predicate device (PS-Unit Cassette/Serum and Urine Combo HCG by International Newtech Development, Inc.). | 100% correlation with the predicate device. |
| Detect hCG in serum and urine at concentrations of 20 ng/mL or greater. | Detects hCG in serum and urine at 20 ng/mL or greater. (vs. predicate device "greater than 20ng/mL") |
| Demonstrate similar sensitivity, specificity, and accuracy to the predicate device. | 100% correlation with the predicate device, implying similar sensitivity, specificity, and accuracy. |
Study Details
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Sample size used for the test set and the data provenance:
- Serum samples: 100 samples (51 positive and 49 negative)
- Urine samples: 105 samples (40 positive and 65 negative)
- Data Provenance: The document does not explicitly state the country of origin. It is implied to be clinical samples from pregnant and non-pregnant women. The study appears to be retrospective, as it describes the evaluation of existing samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth. The ground truth appears to be based on the established pregnancy status of the women from whom the samples were collected.
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Adjudication method for the test set:
- The document does not describe an adjudication method. It states that the samples were evaluated and compared, implying a direct comparison of results between the test device and the predicate device, against known pregnancy status.
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If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of the device in detecting hCG and its correlation with a predicate device, rather than the impact of the device on human reader performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The Advantage hCG Test is an in-vitro diagnostic device (immunochromatographic assay), meaning its performance is evaluated based on its ability to detect the analyte (hCG) in samples, independent of human interpretation beyond reading the test result itself. The study compared the device's results directly with a predicate device and the known status of the samples.
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The type of ground truth used:
- The ground truth was based on the known pregnancy status of the women from whom the urine and serum samples were collected (i.e., "pregnant and non pregnant women"), along with the results from the predicate device. While not explicitly stated as "clinical outcomes data," the known pregnancy status serves as the ultimate clinical ground truth for hCG detection.
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The sample size for the training set:
- The document does not mention a training set as this is an in-vitro diagnostic device (immunochromatographic assay) and likely does not involve machine learning algorithms that require separate training and test sets in the traditional sense. The study described is a performance evaluation or validation study.
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How the ground truth for the training set was established:
- As no training set is mentioned or applicable in the context of this device technology, the method for establishing its ground truth is not applicable.
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(105 days)
The Redi-Test Opiates is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of the opiate compounds including morphine at a cut off concentration of 300 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
The Redi-Test Opiates is an immunochromatograpic based one step in vitro test.
Acceptance Criteria and Device Performance Study for Redi-Test Opiates
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (DRI, Opiate Enzyme Immunoassay) | >99% correlation |
| Detection of morphine and codeine at 300 ng/mL cutoff | Detected (Implied by substantial equivalence to predicate) |
| Qualitative preliminary analytical result | Qualitative preliminary analytical result |
| Requires confirmation by alternate methodology (e.g., GC/MS) | Requires confirmation by alternate methodology (e.g., GC/MS) |
2. Sample Size and Data Provenance
The study used 100 specimens, consisting of 50 negative and 50 positive samples, covering the entire assay range. The provenance of this data (e.g., country of origin, retrospective or prospective) is not specified in the provided document.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts, nor their qualifications, used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set. The comparison appears to be a direct correlation between the Redi-Test Opiates and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. The study described focused on the correlation of the Redi-Test Opiates with a predicate device, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was performed. The Redi-Test Opiates is an immunochromatographic assay, which is a standalone in vitro diagnostic device, not an algorithm requiring human-in-the-loop for its primary performance. The study evaluated the device's performance in detecting opiates in urine samples.
7. Type of Ground Truth Used
The ground truth for the test set was established by the results obtained from the predicate device, the DRI, Opiate Enzyme Immunoassay. This is an indirect ground truth based on the performance of an already legally marketed and accepted device. The document also states that confirmation by an alternate methodology, preferably GC/MS, is required for both the predicate and the Redi-Test, implying that GC/MS would be the ultimate gold standard for confirmation, but it was not used to establish the ground truth for the comparison study itself.
8. Sample Size for the Training Set
The document does not provide information regarding a separate training set. The study described focuses on the comparison of the Redi-Test Opiates to a predicate device using test specimens. As an immunoassay, the device itself is not "trained" in the typical machine learning sense.
9. How Ground Truth for the Training Set was Established
Since no training set is described, this information is not applicable based on the provided document. The device's underlying principles are based on known immunochromatographic reactions, not on learning from a training dataset.
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